FDA approval
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August 22, 2018
FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer Bookmark
Emma Shtivelman, PhDExcerpt from The ASCO Post:
“Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response.
“This approval for nivolumab had been granted Priority Review from the FDA. It was based on data from the SCLC cohort of the ongoing phase I/II CheckMate-032 study evaluating nivolumab monotherapy in patients who experienced disease progression after platinum-based chemotherapy.”
Go to full article published by The ASCO Post on Aug 17, 2018.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.
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August 22, 2018
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC Bookmark
Emma Shtivelman, PhDExcerpt from The ASCO Post:
“Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
“Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.”
Go to full article published by The ASCO Post on Aug 20, 2018.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.
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August 5, 2018
FDA Approves Enzalutamide for Nonmetastatic CRPC Bookmark
Emma Shtivelman, PhDExcerpt from OncLive:
“The FDA has approved enzalutamide (Xtandi) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent.
“The approval is based on the phase III PROSPER trial, in which the combination of enzalutamide (Xtandi) and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71% compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with enzalutamide plus ADT versus 14.7 months with ADT alone (HR, 0.29; 95% CI, 0.24-0.35; P <.0001).”
Go to full article published by OncLive on July 13, 2018.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.
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July 16, 2018
Proposed FDA “Conditional Approval”- More Details
With: Marty Tenenbaum, PhDAl Musella, DPMA Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published May 10, 2017 Q: Your April 5, 2017 blog post that proposed a new “Conditional” category for FDA drug approval elicited a number of positive and negative responses. Please explain the proposal in more detail… Read more »
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July 9, 2018
Conditional Approval: Right Solution for the Wrong Problem
With:A Q&A with Shannon Brownlee, MS, Senior Vice President of the Lown Institute, a think tank in Boston. She is also co-founder of the Right Care Alliance, a social movement for transforming health care. Originally published April 26, 2017 Q: Musella and Tenenbaum recently proposed a new way, called conditional approval, for the American FDA to move potentially useful drugs to a patient market.… Read more »
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July 2, 2018
A Proposed New FDA Drug Approval Pathway: “Conditional”
With: Marty Tenenbaum, PhDAl Musella, DPMA Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published April 5, 2017 Q: The delay time from discovery/observation, through validation to approval and distribution/use of new cancer treatments remains excessive. With promising experimental treatments, advanced computer technology and biostatistics, creative alternatives… Read more »
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May 29, 2018
Practice-Changing Developments in Treatment of Metastatic NSCLC
Emma Shtivelman, PhDImmune checkpoint inhibitor drugs that target the proteins PD-1 and PD-L1 are by now well established in the treatment of non-small cell lung cancer (NSCLC). In 2015, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo), an anti-PD-1 drug, for treatment of patients with metastatic NSCLC who progressed or relapsed after platinum-based chemotherapy. Atezolizumab (Tecentriq), an anti-PD-L1 drug, was approved in 2016 for… Read more »
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December 5, 2017
FDA Aims to Expand Early-Approval Program for Promising Drugs Bookmark
Emma Shtivelman, PhDExcerpt:
“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.
“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.
“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”
Go to full article published by Bloomberg on Nov 30, 2017.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.
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November 10, 2016
War of the Checkpoint Inhibitors: Anti-PD-1 Drugs Move into First-Line Treatment in NSCLC
Emma Shtivelman, PhDLast year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their… Read more »
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March 11, 2016
New Treatments for Gastrointestinal Neuroendocrine Tumors
Emma Shtivelman, PhDNeuroendocrine tumors (NETs) of the digestive system (GI-NETs) can arise in different parts of the digestive tract…Two new treatments for GI-NETs recently received much attention at the 2016 Gastrointestinal Cancers Symposium held in San Francisco in January. Researchers at the symposium presented clinical trial results that demonstrated the benefits of these new drugs.